This application relates to a marking system for proper connection of a connector with an energy source such as an implantable electrical stimulator.
Connector assemblies are used to couple a conductor with a device. For instance, a connector is used to couple a cardiac stimulator system such as a pacemaker, an anti-tachycardia device, a cardioverter or a defibrillator with a lead having an electrode for making contact with a portion of the heart.
There are many different lead connectors and headers in use today. For example, there is VS1/IS1 short pin, 3.2 mm long pin, 3.2 mm low profile long pin, 3.2 mm short pin, 5 mm long pin, etc. Furthermore, there are many different types of terminal connections in headers used in pulse generators. For example, there is IS-1, VS-1, VS-1B, VS-1A, 5/6 Header, etc.
For each combination of lead connector and header, the lead connector is advanced into the header a different distance for proper seating. It is often difficult to differentiate between a lead that is seated correctly and one that is not advanced far enough. When inserted into the pacemaker, the components of the terminal connection undergo axial stress as the physician forces the proximal end of the lead into the pacemaker. This can result in damage to the lead or connector if the physician tries to push the connector further into the header than designed.
After insertion of the connector within the pulse generator, the physician may pull on the lead to ensure the terminal end is sufficiently seated in the pacemaker, placing additional axial stress on the terminal connection. Alternatively, if the connector is not seated far enough within the header, an improper electrical connection will likely occur. An improper electrical connection is typically not detected until the pulse generator is placed in a pocket of tissue within a patient and testing of the lead has begun. If the lead must be reseated within the header, additional time and potentially additional trauma to the patient is incurred. Additional time is wasted due to uncertainty of the connection, as the physician moves the pulse generator around or squints at the device to determine whether the connector has been properly seated within the pulse generator. As newer systems increase the number of leads and connectors, the amount of time wasted during insertion of the lead increases.
Accordingly, what is needed is a system which allows a physician to establish quickly and with certainty whether a lead has been properly seated within an energy source.
A marking system to enable physicians to quickly and decisively determine whether a connector is properly seated within the pulse generator.
An assembly is provided including a header with an energy source. The assembly further includes at least one first connector extending from a terminal end to a distal end, and the terminal end is disposed within a first opening of the header. The header includes at least one header marking thereon, and the terminal end of the connector has at least one connector marking thereon, where the connector marking matches the header marking. The at least one connector marking provides a visual indication of proper placement of the connector within the header.
Several options for the assembly are as follows. For instance, in one option, the header marking is disposed around the first opening of the header, and the header marking is disposed on an external surface of the header. The connector marking, in one option, is disposed completely within the header when the connector is properly seated therein. In another option, the header marking includes a first header marking of a first color, a second header marking of a second color, and the first color is different than the second color. In yet another option, the connector marking includes a first connector marking of a first color, a second connector marking of a second color, and the first color is different than the second color, and optionally the first and second connectors include a third color marking that, when properly inserted, line up with one another. The assembly, in another option, includes a first connector having a first color marking and a second connector having a second color marking, and the header marking includes the first color marking and the second color marking thereon. In yet another option, the header is translucent, and optionally a color is embedded adjacent to the at least one opening.
In yet another embodiment, a system includes a pulse generator having an energy source, and a connector coupled with a lead. The lead has a lead body and at least one electrode, and the connector is coupled with the pulse generator. The system further includes a means for visually indicating when the connector is properly seated within the pulse generator, where the means for visually indicating is applied to the connector and an external surface of the pulse generator.
Several options for the assembly are as follows. For example, in one option, the pulse generator includes a color marking thereon, the color marking disposed directly adjacent to an opening of the pulse generator. In another option, the color marking is disposed around a perimeter of the opening of the pulse generator, and the opening receives the connector therein.
In another embodiment, the system includes a lead and a lead body, and a connector coupled with the lead. The system further includes a pulse generator with an opening, and the opening is sized and configured to receive the connector therein. The system further includes a first visual indicator marked around the opening of the pulse generator, and a connector marking disposed on the terminal end of the connector. The connector marking is substantially similar as the first visual indicator.
Several options for the system are as follows. For instance, in one option, the first visual indicator has a first color, the connector marking has a second color, and the first color matches the second color. In another option, the visual indicator has a first pattern, the connector marking has a second pattern, and the first pattern matches the second pattern. In yet another option, the pulse generator includes a second opening therein. The second opening has a second visual indicator marked around the second opening, where the second visual indicator is different than the first visual indicator. The system optionally further includes a second lead with a second connector, and the second connector includes a second connector marking thereon. The second connector marking is substantially similar to the second visual indicator.
In another embodiment, a method includes marking a connector with at least a first connector visual indicator, marking an external surface of a header with a first header visual indicator, where the first header visual indicator matches the first connector visual indicator. The method further includes inserting the connector into the header, and stopping insertion of the connector into the header once the first connector visual indicator is no longer visible.
Several options for the method are as follows. For instance, in one option, marking the connector comprises marking the connector with a color marking. In another option, marking the header comprises marking the header with a color marking. In yet another option, marking the header comprises marking around an opening of the header, and inserting the connector includes inserting the connector into the opening. The method, in another option, further includes marking a second lead with a second connector visual indicator, disposing the second lead into the second opening, and stopping insertion of the second lead into the second opening when the second connector visual indicator is no longer visible. In another option, marking the header comprises marking around a first opening with the first header visual indicator, and marking around a second opening with a second header visual indicator.
The marking system allows for a physician to easily identify whether or when a lead has been properly seated within a header. Furthermore, the system provides for an effective and inexpensive marking system. The system further assists in preventing unnecessary stress exerted on the lead, for example, by a physician checking whether a lead has been properly placed within the header. Still further, the system allows proper identification of leads relative to their appropriate openings within the header.
These and other embodiments, aspects, advantages, and features of the present invention will be set forth in part in the description which follows, and in part will become apparent to those skilled in the art by reference to the following description of the invention and referenced drawings or by practice of the invention. The aspects, advantages, and features of the invention are realized and attained by means of the instrumentalities, procedures, and combinations particularly pointed out in the appended claims and their equivalents.